A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study in Healthy Volunteers and a Phase 2a, Open-Label Study in Patients With Hereditary Angioedema to Evaluate the Safety, Tolerability, PK and PD of ADX-324
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-324 in healthy volunteers (HV) and in patients with Hereditary Angioedema (HAE).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Male and female adults 18 to 55 years old
• Body mass index (BMI) between 18 and 30 kg/m2
• Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Willing and able to provide informed consent and comply with all study visits
• Male and female ≥18 years old, inclusive, at the time of signing the PICF
• Confirmed diagnosis of HAE Types I or II
• Evidence of an average of (at least) one HAE attack per month
• Participants must have access to, and the ability to use, acute medication(s) to treat angioedema attacks.
• Body mass index (BMI) between 18 and 30 kg/m2
• Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
• Willing and able to provide informed consent and comply with all study visits
Locations
Other Locations
Australia
CMAX Clinical Research
RECRUITING
Adelaide
Contact Information
Primary
Lisa Melia, MA
lmelia@adarx.com
877-232-7974
Time Frame
Start Date:2022-12-14
Estimated Completion Date:2026-01-31
Participants
Target number of participants:53
Treatments
Experimental: PART A - Active ADX-324 administered to HV
For each cohort in Part A (SAD), 8 participants will be randomized in a 3:1 ratio; 6 participants to active (ADX-324): 2 participants to control (matched placebo). Randomization will be on Day 1. Initially, 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. The sentinel participants will be evaluated for safety. The investigator's assessment and the independent medical monitor will decide upon the randomization and dosing of the 6 remaining participants (5 active and 1 placebo) according to the randomization schedule.
Placebo_comparator: PART A- Placebo administered to HV
For each cohort in Part A (SAD), 8 participants will be randomized in a 3:1 ratio; 6 participants to active (ADX-324): 2 participants to control (matched placebo). Randomization will be on Day 1. Initially, 2 sentinel participants (1 active and 1 placebo) will be randomized and dosed. The sentinel participants will be evaluated for safety. The investigator's assessment and the independent medical monitor will decide upon the randomization and dosing of the 6 remaining participants (5 active and 1 placebo) according to the randomization schedule.
Experimental: PART B - ADX-324 administered to HAE participants
This will be initiated at the dose level determined by the Safety Review Committee from SAD in HVs. The treatment of HAE participants is an open-label study.